Label: DAYTIME MULTI-SYMPTOM COLD/FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 33992-0611-0 - Packager: Greenbrier International
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 28, 2012
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- Official Label (Printer Friendly)
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- Active ingredients
- Purpose
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning
If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- symptoms get worse or last more than 5 days (children) or 7 days (adults)
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions?
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- PRINCIPAL DISPLAY PANEL - 10 Softgel Carton
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INGREDIENTS AND APPEARANCE
DAYTIME MULTI-SYMPTOM COLD/FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0611 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 10 mg Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg Inactive Ingredients Ingredient Name Strength FD&C Red No. 40 (UNII: WZB9127XOA) FD&C Yellow No. 6 (UNII: H77VEI93A8) gelatin (UNII: 2G86QN327L) glycerin (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) polyethylene glycols (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) propylene glycol (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) sorbitol (UNII: 506T60A25R) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score no score Shape OVAL Size 21mm Flavor Imprint Code RP061 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-0611-0 1 in 1 CARTON 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/01/2013 Labeler - Greenbrier International (610322518)
